Artemether API Manufacturers & Suppliers

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Tenatra Exports Private Limited

Distributor

Produced in India

Employees: 10

Audit Report:

Certifications: GMP

FDA

MSDS

BSE/TSE

CoA

All certificates

GMP

FDA

MSDS

BSE/TSE

CoA

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Hänseler AG

Distributor

Produced in Switzerland

Employees: 135+

Audit Report:

Certifications: GMP

MSDS

CoA

All certificates

GMP

MSDS

CoA

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Chr. Olesen Group

Distributor

Produced in India

Employees: 150

Audit Report:

Certifications: USDMF

CoA

All certificates

USDMF

CoA

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Mangalam Drugs & Organics

Producer

Produced in India

Audit Report:

Certifications: GMP

CoA

All certificates

GMP

CoA

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Vital Laboratories Pvt. Ltd.

Producer

Produced in India

Audit Report:

Certifications: USDMF

CoA

All certificates

USDMF

CoA

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Shanghai Desano Chem.

Producer

Produced in China

Audit Report:

Certifications: GMP

CoA

All certificates

GMP

CoA

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Ipca Labs.

Producer

Produced in India

Audit Report:

Certifications: GMP

CoA

All certificates

GMP

CoA

Not active

Micro Labs

Producer

Produced in India

Audit Report:

Certifications: USDMF

CoA

All certificates

USDMF

CoA

Not active

Shaoxing Hantai Pharma

Distributor

Produced in China

Audit Report:

Certifications: coa

All certificates

coa

Not active

Cipla

Producer

Produced in India

Audit Report:

Certifications: GMP

CoA

All certificates

GMP

CoA

Not active

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Artemether | CAS No: 71963-77-4 | GMP-certified suppliers

A medication that supports reliable treatment of acute uncomplicated malaria, including chloroquine‑resistant Plasmodium falciparum infections and unidentified species cases, for broad clinical applicability in global programs.

Therapeutic categories

Anti-Infective AgentsAntimalarialsAntiparasitic AgentsAntiparasitic Products, Insecticides and RepellentsAntiprotozoalsArtemisinin and derivatives

Generic name

Artemether

Molecule type

small molecule

CAS number

71963-77-4

DrugBank ID

DB06697

Approval status

Approved drug

ATC code

P01BF01

Primary indications

Artemether and lumefantrine combination therapy is indicated for the treatment of acute uncomplicated malaria caused by <i>Plasmodium falciparum</i>, including malaria acquired in chloroquine-resistant areas
May also be used to treat uncomplicated malaria when the <i>Plasmodium</i> species has not been identified
Indicated for use in adults and children greater than 5 kg

Product Snapshot

Artemether is supplied as an injectable and oral small‑molecule API for combination antimalarial formulations
It is used in products targeting acute uncomplicated Plasmodium falciparum malaria, including chloroquine‑resistant cases and unspecified Plasmodium infections
It is approved for the US market with FDA authorization

Clinical Overview

Artemether (CAS 71963-77-4) is an artemisinin derivative used with lumefantrine for the treatment of acute uncomplicated malaria. The combination is indicated for infections caused by Plasmodium falciparum, including those acquired in chloroquine‑resistant regions, and for cases in which the Plasmodium species has not been identified. It is approved for adults and for pediatric patients weighing more than 5 kg.

Artemether belongs to the artemisinin class of sesquiterpenoids derived from Artemisia annua. Its structure incorporates a peroxide bridge that is central to its pharmacological activity. Following administration, artemether is rapidly converted to dihydroartemisinin, the primary active metabolite responsible for most of the antimalarial effect.

Pharmacodynamic activity is directed against the erythrocytic stages of P. falciparum. The drug is thought to impair nucleic acid and protein synthesis, contributing to rapid parasite clearance. Lumefantrine, with its longer elimination half-life, complements this activity by maintaining therapeutic levels to eliminate residual parasites and reduce recrudescence risk.

The mechanism of action involves interaction with ferriprotoporphyrin IX within the parasite’s acidic food vacuole. Contact between the peroxide moiety and heme or ferrous ions generates reactive oxygen and carbon-centered radical species, which are cytotoxic to the parasite. This process underlies the broad activity of peroxide-containing antimalarials.

Artemether exhibits rapid absorption and clearance, with metabolism primarily via CYP3A isoenzymes. It is also listed as a substrate and weak inducer of several CYP enzymes, which may have implications for drug–drug interactions. Safety considerations include the potential for QT interval prolongation, particularly in combination with other QT‑prolonging agents. Gastrointestinal and neurologic adverse effects have been reported but are generally transient.

Notable fixed-dose combinations include artemether–lumefantrine products widely used in global malaria control programs. For API procurement, suppliers should provide evidence of compliance with pharmacopeial specifications, control of peroxide degradation pathways, and robust stability data to support manufacturing and regulatory submissions.

Identification & chemistry

Generic name	Artemether
Molecule type	Small molecule
CAS	71963-77-4
UNII	C7D6T3H22J
DrugBank ID	DB06697

Pharmacology

Summary	Artemether is rapidly converted to dihydroartemisinin, which interacts with heme in the parasite food vacuole to generate reactive radical species that disrupt nucleic acid and protein synthesis in erythrocytic Plasmodium falciparum. Lumefantrine has a slower elimination profile and complements artemether by sustaining antimalarial activity to clear remaining parasites. Together, the agents target heme‑dependent pathways central to parasite survival.
Mechanism of action	Involves an interaction with ferriprotoporphyrin IX (“heme”), or ferrous ions, in the acidic parasite food vacuole, which results in the generation of cytotoxic radical species. The generally accepted mechanism of action of peroxide antimalarials involves interaction of the peroxide-containing drug with heme, a hemoglobin degradation byproduct, derived from proteolysis of hemoglobin. This interaction is believed to result in the formation of a range of potentially toxic oxygen and carbon-centered radicals.
Pharmacodynamics	In the body, artemether is metabolized into the active metabolite metabolite dihydroartemisinin. The drug works against the erythrocytic stages of <i>P. falciparum</i> by inhibiting nucleic acid and protein synthesis. Artemether is administered in combination with lumefantrine for improved efficacy. Artemether has a rapid onset of action and is rapidly cleared from the body. It is thought that artemether provides rapid symptomatic relief by reducing the number of malarial parasites. Lumefantrine has a much longer half life and is believed to clear residual parasites.

ADME / PK

Absorption	Food increases absorption.
Half-life	Artemether, 1.6 +/- 0.7 and 2.2 +/- 1.9 hr; Dihydroartemisinin, 1.6 +/- 0.6 and 2.2 +/- 1.5 hr
Protein binding	Artemether and lumefantrine are both highly bound to human serum proteins in vitro (95.4% and 99.7%, respectively). Dihydroartemisinin is also bound to human serum proteins (47% to 76%).
Metabolism	Rapidly metablized to its active metabolite, dihydroartemisinin.

Formulation & handling

Oral formulations benefit from administration with food due to increased absorption, while avoiding grapefruit products to limit interaction risk.
Low aqueous solubility and moderate lipophilicity require solubility‑enhancing strategies for oral dosage forms.
The internal peroxide bridge warrants protection from heat and reductive conditions during processing and storage.

Regulatory status

Lifecycle	Insufficient information is provided to determine the patent status or lifecycle stage of the API. Please share the patent expiry year (or whether patents have expired) so I can generate an accurate 1–2‑sentence lifecycle summary.

Markets	US

Supply Chain

Supply chain summary	Artemether is associated with a single originator manufacturer, primarily through the fixed‑dose artemether–lumefantrine combination. Branded products such as Coartem have global distribution beyond the United States, with long‑established use in multiple malaria‑endemic regions. Core patents have expired, and the product class already supports broad generic competition.

Safety

Toxicity	Animal studies on acute toxicity show that the LD50 of Artemether in mice is a single i.g. administration of 895mg/kg and a single i.m. injection of 296mg/kg dose; in rats, the LD50 is a single i.m. injection of 597mg/kg dose.

High Level Warnings:

High acute toxicity in rodents (mouse LD50: 895 mg/kg i
G
296 mg/kg i

US Drug Master File (USDMF)

A US Drug Master File (USDMF) is a confidential document submitted to the U.S. Food and Drug Administration (FDA) that provides detailed information about the manufacturing process of an Active Pharmaceutical Ingredient (API) or a finished pharmaceutical product. This document includes comprehensive details such as chemical properties, manufacturing facilities, production processes, packaging specifications, storage conditions, and more.

The USDMF ensures that proprietary information remains protected while allowing the FDA to review the data as part of drug approval processes. Unlike other types of DMFs used in different regions, the USDMF is specifically designed to meet the regulatory requirements set by the FDA, ensuring compliance with U.S. standards.

Artemether is a type of Antimalarial

The Antimalarial category of pharmaceutical APIs encompasses a range of active ingredients used in the development of drugs to treat and prevent malaria, a life-threatening infectious disease caused by the Plasmodium parasite. These APIs are crucial in formulating effective antimalarial medications.

One widely used API in this category is Artemisinin, derived from the Artemisia annua plant. It exhibits potent antimalarial properties and is a key component in various combination therapies. Another prominent API is Chloroquine, an aminoquinoline compound that has been historically used as a primary treatment for malaria. However, due to emerging drug resistance, alternative APIs like Mefloquine and Quinine have gained prominence.

These APIs work by interfering with the life cycle of the Plasmodium parasite. They inhibit various stages of parasite development, such as preventing the replication of the parasite's DNA and disrupting its metabolic processes. By targeting the parasite, antimalarial APIs help to control and eliminate the infection, reducing the severity of symptoms and preventing complications.

The development and production of high-quality antimalarial APIs require stringent quality control measures to ensure their safety and efficacy. Pharmaceutical companies adhere to strict regulations and guidelines to guarantee the purity, stability, and bioavailability of these APIs. Additionally, ongoing research aims to discover new antimalarial APIs and formulations to combat drug resistance and improve treatment outcomes.

In conclusion, the Antimalarial category of pharmaceutical APIs plays a vital role in the formulation of drugs used to treat and prevent malaria. These APIs, such as Artemisinin, Chloroquine, Mefloquine, and Quinine, effectively target the Plasmodium parasite, aiding in the management and eradication of malaria infections.

Artemether API manufacturers & distributors

Compare qualified Artemether API suppliers worldwide. We currently have 10 companies offering Artemether API, with manufacturing taking place in 3 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.

Supplier	Type	Country	Product origin	Certifications	Portfolio
Chr. Olesen Group	Distributor	Denmark	India	CoA, USDMF	252 products
Cipla	Producer	India	India	CoA, GMP, WC	164 products
Hänseler AG	Distributor	Switzerland	Switzerland	CoA, GMP, MSDS	174 products
Ipca Labs.	Producer	India	India	CoA, GMP, WC	69 products
Mangalam Drugs & Organics...	Producer	India	India	CoA, GMP, WC	10 products
Micro Labs	Producer	India	India	CoA, USDMF	38 products
Shanghai Desano Chem.	Producer	China	China	CoA, GMP	22 products
Shaoxing Hantai Pharma	Distributor	China	China	CoA	162 products
Tenatra Exports Private L...	Distributor	India	India	BSE/TSE, CoA, FDA, GMP, MSDS	263 products
Vital Laboratories Pvt. L...	Producer	India	India	CoA, USDMF, WC	22 products

When sending a request, specify which Artemether API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).

Use the list above to find high-quality Artemether API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.

Frequently asked questions about Artemether API

Sourcing

What matters most when sourcing GMP-grade Artemether?

Key considerations include confirming GMP compliance and U.S. regulatory suitability of the manufacturing site. Because Artemether supply is linked to a single originator source, verification of consistent quality systems and batch documentation is essential. With patents expired and generic production established, ensuring the selected supplier meets U.S. expectations for identity, purity, and impurity control remains the primary focus.

Which documents are typically required when sourcing Artemether API?

Request the core API documentation set: CoA (10 companies), GMP (6 companies), WC (4 companies), USDMF (3 companies), MSDS (2 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.

Which manufacturers are known to produce Artemether API?

Known or reported manufacturers for Artemether: Hänseler AG, Chr. Olesen Group, Tenatra Exports Private Limited. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.

How can I request quotes for Artemether API from GMP suppliers?

Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.

Is a GMP audit report available for Artemether manufacturers?

Audit reports may be requested for Artemether: 3 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.

How many suppliers offer Artemether API on Pharmaoffer?

Reported supplier count for Artemether: 10 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.

Which countries are known to manufacture Artemether API?

Production countries reported for Artemether: India (7 producers), China (2 producers), Switzerland (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.

Which certifications do suppliers of Artemether usually hold?

Common certifications for Artemether suppliers: CoA (10 companies), GMP (6 companies), WC (4 companies), USDMF (3 companies), MSDS (2 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.

Technical

What is Artemether (CAS 71963-77-4) used for?

Artemether is used in combination with lumefantrine to treat acute uncomplicated malaria caused by Plasmodium falciparum, including infections acquired in chloroquine‑resistant areas and cases where the infecting species has not been identified. It targets the erythrocytic stages of the parasite and is approved for adults and pediatric patients weighing more than 5 kg.

Which therapeutic class does Artemether fall into?

Artemether belongs to the following therapeutic categories: Anti-Infective Agents, Antimalarials, Antiparasitic Agents, Antiparasitic Products, Insecticides and Repellents, Antiprotozoals. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.

What conditions is Artemether mainly prescribed for?

The primary indications for Artemether: Artemether and lumefantrine combination therapy is indicated for the treatment of acute uncomplicated malaria caused by Plasmodium falciparum, including malaria acquired in chloroquine-resistant areas, May also be used to treat uncomplicated malaria when the Plasmodium species has not been identified, Indicated for use in adults and children greater than 5 kg. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.

How does Artemether work?

Involves an interaction with ferriprotoporphyrin IX (“heme”), or ferrous ions, in the acidic parasite food vacuole, which results in the generation of cytotoxic radical species. The generally accepted mechanism of action of peroxide antimalarials involves interaction of the peroxide-containing drug with heme, a hemoglobin degradation byproduct, derived from proteolysis of hemoglobin. This interaction is believed to result in the formation of a range of potentially toxic oxygen and carbon-centered radicals.

What should someone know about the safety or toxicity profile of Artemether?

Artemether shows high acute toxicity in rodent studies, with reported LD50 values in mice indicating significant dose‑dependent lethality. In clinical use, key safety considerations include the risk of QT interval prolongation, especially when combined with other QT‑prolonging drugs. Gastrointestinal and neurologic effects can occur but are typically transient. As a CYP3A substrate and weak inducer, it may participate in drug–drug interactions.

What are important formulation and handling considerations for Artemether as an API?

Artemether’s low aqueous solubility and moderate lipophilicity require solubility‑enhancing approaches such as lipid‑based systems or appropriate surfactants in oral formulations. The internal peroxide bridge is sensitive to heat and reductive conditions, so processing and storage should minimize exposure to elevated temperatures and reducing agents. Oral products should account for increased absorption with food and avoid co‑administration with grapefruit products to limit interaction risk. High protein binding and rapid metabolism to dihydroartemisinin should be considered when selecting excipients that do not interfere with these properties.

Is Artemether a small molecule?

Artemether is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.

Are there special stability concerns for oral Artemether?

Oral Artemether requires protection from heat and reductive conditions because its internal peroxide bridge is chemically sensitive. Its low aqueous solubility also necessitates formulation approaches that maintain dissolution and stability during storage. Avoiding grapefruit products helps limit interaction risk but is not a stability concern for the product itself.

Regulatory

Where is Artemether approved or in use globally?

Artemether is reported as approved in the following major regions: US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.

What’s the regulatory and patent landscape for Artemether right now?

In the US, Artemether is regulated under FDA requirements for manufacturing quality, safety, and applicable approvals. Patent considerations follow standard US pharmaceutical patent frameworks and must be assessed through established patent records and regulatory listings.

Pharmaoffer

How does Pharmaoffer’s Smart Sourcing Service help with Artemether procurement?

Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Artemether. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.

Is Artemether included in the PRO Data Insights coverage?

PRO Data Insights coverage for Artemether: 2535 verified transactions across 498 suppliers and 256 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.

Where can I access the API market report for Artemether?

Market report availability for Artemether: . The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.